Medication Therapy Management With Pharmacogenetic Testing

NCT01970774 — Not applicable, Completed, 30 participants, Duke University

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Assessing Feasibility and Utility of Enhancing Medication Therapy Management With Pharmacist-Delivered Pharmacogenetic Testing

Registry	NCT01970774
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	30 (Actual)
Sponsor	Duke University (Other)
Conditions	Pharmacogenetics, Medication Therapy Management
Interventions	MTM with PGx (Other)
Dates	start 2013-11-01, primary completion 2014-10-01, completion 2014-10-01, first posted 2013-10-28, last updated 2015-04-20
Locations	1 site in United States

-Summary

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

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+Arms and interventions

Arm	Type	Interventions	Description
MTM and PGx	Experimental	Other: MTM with PGx	Participants attend two MTM sessions and have PGx testing

MTM with PGx (Other): Patients will attend MTM sessions and receive PGx testing

+Outcome measures

Primary outcomes

Patient satisfaction with MTM and PGx [3 months after completion of MTM2]: This will be assessed by a quantitative survey
Change in clinical biomarkers associated with drug therapy [baseline and 2 months]: Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control
Number of recommended drug selection/dosing adjustments [approximately 9 months]: Drug selection/doing changes will be compared between study population and chart-review controls

Secondary outcomes

Physician time to perform MTM and PGx [end of study, approx. 9 months]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
* 18 years of age or older
* English speaking
* patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

Exclusion Criteria:

* if patient has ever had MTM or PGx

+Locations (1)

Facility	City	Country	Status
Duke Health Center at Southpoint	Durham, North Carolina	United States

+Investigators

Susanne Haga, PhD, Principal investigator, Duke University